Below is information and a statement from New Hanover County regarding the Johnson & Johnson vaccine. Also included below is a statement from the CDC and FDA:
New Hanover County Public Health received information this morning from the North Carolina Department of Health and Human Services with a recommendation to pause the use of the Johnson & Johnson vaccine out of an abundance of caution, while the CDC and FDA review possible and very rare cases of blood clots as a result of the vaccine. People who have received the J&J vaccine should continue monitoring their health, and contact their primary healthcare provider about any side effects they may be experiencing. In addition, residents should report any possible side effects (called adverse events) to the CDC’s Vaccine Adverse Event Reporting System (VAERS). This national system collects data to look for adverse events that are unexpected, appear to happen more often than expected, or have unusual patterns of occurrence.
It is normal for people to experience temporary reactions after receiving a COVID-19 vaccine such as a sore arm, headache or feeling tired and achy for a day or two and in some cases, fever or nausea. In most cases, these temporary reactions are normal and are good signs that the body is building protection.
The vaccination clinics currently planned through New Hanover County Public Health are using the Pfizer and Moderna vaccines, so no planned clinics will be impacted by this pause in administering the J&J vaccine.
According to New Hanover County Public Health Director David Howard: “The FDA has paused use of the Johnson & Johnson COVID-19 vaccine after six people in the US developed a rare blood-clotting disorder. These reported adverse reactions are extremely rare, and we want to encourage the public to continue trusting the FDA-approved vaccines because they are effective at preventing serious illness and death from COVID-19 and are a key factor in helping to end this pandemic. Public Health will continue to monitor this evolving review and assessment of the J&J vaccine, and will continue its work in promoting and protecting the health of our residents.”
The following statement is attributed to Dr. Anne Schuchat, Principal Deputy Director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research
As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.
CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.
Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.
CDC and FDA will provide additional information and answer questions later today at a media briefing. A recording of that media call will be available on the FDA’s YouTube channel.